Label: DALIVIT- ascorbic acid, folic acid, niacinamide, thiamine hydrochloride, riboflavin, pyridoxine hydrochloride, cyanocobalamin and calcium pantothenate capsule, coated

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated April 6, 2018

If you are a consumer or patient please visit this version.

  • HEALTH CLAIM

    Rx Only

  • DESCRIPTION

    DAIVIT is a prescription multi-vitamin in the form of a red, oval, softgel.

  • INDICATION AND USAGE

    DALIVIT is a prescription multi-vitamin supplement that can be taken to improve nutritional status in conditions requiring dietary supplementation. DALIVIT can also be used for the dietary management of individuals with distinct nutritional needs under a physician or healthcare provider’s supervision for end stage failure, dialysis, hyperhomocysteinemia or inadequate dietary vitamin intake.

  • CONTRAINDICATIONS

    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

  • WARNING

    Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

    DO NOT EXCEED RECOMMENDED DOSAGE.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

  • PRECAUTIONS

    Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. The 1 mg of cyanocobalamin contained in DALIVIT Softgels has been shown to provide an adequate amount of cyanocobalamin to address this precaution. A safer upper limit of 100 mg per day has been established for the unsupervised medical use of pyridoxine. Consider all sources of pyridoxine supplementation when prescribing DALIVIT Softgels.

    If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or healthcare provider before using or continuing use of this medication.

  • ADVERSE REACTIONS

    Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Paresthesia and somnolence have been reported with the use of pyridoxine hydrochloride. Mild transient diarrhea, polycynthemia vera, peripheral vascular thrombosis, itching transitory exanthema and feeling of swelling of the entire body has been associated with the use of cyanocobalamin.

  • DRUG INTERACTIONS

    Pyridoxine supplements should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine. However, pyridoxine may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folacin (folic acid) may result in decreased phenytoin effectiveness.

  • DOSAGE AND ADMINISTRATION

    Adults: One Softgel taken orally daily or as directed by a physician.

    DO NOT EXCEED RECOMMENDED DOSAGE.

  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size: 1 SoftgelServings per Container: 30
    Amount Per Serving          % Daily Value
      Vitamin C (as Ascorbic Acid)100mg167%
      Folic Acid 1mg250%
      Vitamin B1 (as Thiamine HCl)2mg133%
      Vitamin B2 (as Riboflavin)2mg117%
      Vitamin B3 (as Niacinamide)20mg100%
      Vitamin B6 (as Pyridoxine HCl)10mg400%
      Vitamin B12 (as Cyanocobalamin)1mg16,667%
      Pantothenic Acid (as Calcium Pantothenate)10mg100%
  • STORAGE

    Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

    Protect from light and moisture.
    Dispense in a well-closed, tight, light-resistant container as defined by the USP using a child resistant closure.

  • HOW SUPPLIED

    DALIVIT softgels are supplied as red softgel. DALIVIT softgels are available in bottles of 30 (70877-8243-3). Each softgel of Dalivit contains 100 mg ascorbic acid, 1 mg of Folic Acid, 2 mg of thiamine hydrochloride, 2 mg of riboflavin, 20 mg of niacinamide, 10 mg of pyridoxine hydrochloride, 1 mg of cyanocobalamin, and 10 mg of calcium pantothenate.

    Distributed By:
    Taleos Pharma Corp.
    Eatontown, NJ 07724
    www.taleos-pharma.com

  • PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label

    70877-8243-3

    DALIVIT

    PRESCRIPTION
    MULTI-VITAMINS

    Rx Only        30 SOFTGELS

    DIETARY SUPPLEMENT

    PRINCIPAL DISPLAY PANEL - 30 Caplet Bottle Label
  • INGREDIENTS AND APPEARANCE
    DALIVIT 
    ascorbic acid, folic acid, niacinamide, thiamine hydrochloride, riboflavin, pyridoxine hydrochloride, cyanocobalamin and calcium pantothenate capsule, coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:70877-8243
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE2 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN2 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE10 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN1 mg
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737, CALCIUM CATION - UNII:2M83C4R6ZB) PANTOTHENIC ACID10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:70877-8243-330 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT03/09/2018
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)10 mm
    Labeler - Taleos Pharma (080318529)